Cook
Medical has received U.S. Food and Drug Administration (FDA)
marketing approval for the first devices in its Zilver®
PTX® Drug-Eluting Peripheral Stentportfolio,
company officials reported today. It’s the first time the FDA has
approved a drug-eluting stent to treat blockages in a peripheral artery.

“This approval marks the start of Cook’s program to bring the benefits
of drug elution to U.S. physicians treating the peripheral arteries,”
said Rob Lyles, vice president and global leader of Cook Medical’s
Peripheral Intervention division. “No other company can match Cook’s
commitment to this technology, and by the end of 2013, we expect to have
a full suite of drug-eluting peripheral stents in the most commonly used
lengths and diameters available to U.S. physicians.”

In order to supply as many physicians as possible with this new
technology, Cook is making Zilver PTX available initially in 80 mm
lengths in 6 mm and 7 mm diameters. The products indications for use
also allow two Zilver PTX 80 mm stents to be overlapped to treat longer
lesions up to 140 mm. The FDA approval also includes 40 mm and 60 mm
lengths, which will be introduced to the U.S. early in 2013. Cook
expects to receive regulatory approval for 120 mm length stents in both
diameters next year.

Data from Cook’s pivotal clinical trial indicate:

Eight out of ten patients treated with Zilver PTX still had open
arteries (primary patency) after one year1. That compares
to only 3 out of 10 patients treated with angioplasty alone.

Patients who received a bare metal stent required more than twice as
many reintervention procedures to reopen the SFA as patients who
received Zilver PTX. 2

“After conducting the largest randomized controlled study of peripheral
stenting ever undertaken, we now see remarkable results in patients
treated with Zilver PTX,” said Michael Dake, M.D., a professor in the
Department of Cardiothoracic Surgery at Stanford University School of
Medicine and medical director of the Cath/Angio Laboratories at Stanford
Medical Center, Palo Alto, Calif.

“With this approval, treating PAD in the U.S. will begin to undergo the
same revolution that drug elution did for treating coronary artery
disease,” added Gary Ansel, M.D., director for the Center for Critical
Limb Care at Riverside
Methodist Hospital in Columbus, Ohio, and an assistant clinical
professor of medicine in the Department of Internal Medicine at the
University of Toledo Medical Center in Toledo, Ohio. “Drug-eluting
stents such as Zilver PTX will move quickly, in my opinion, to become
the standard of care for PAD patients worldwide.”

Cook’s Zilver PTX stent is already approved for sale in more than 50
markets, including the European Union, Japan, Brazil and most of South
America, Australia, New Zealand and Taiwan. The device is being
introduced to the U.S. market in a five-step process designed to make
this technology available to as many patients as possible initially.

(Drs. Dake and Ansel, who served as global principal investigators for
the Zilver PTX clinical trial, are paid consultants to Cook Medical with
respect to its medical devices.)

About Zilver PTX

How does Zilver PTX work?

A physician gains arterial access through the groin and guides a Zilver
PTX stent to the narrowed artery with a catheter. The stent is deployed
and expands like a scaffold to help keep the artery open after the
catheter is withdrawn. The drug paclitaxel, which coats the stent, is
taken up by the cells of the arterial wall to help prevent the
renarrowing of the artery over time.

CIO, CTO & Developer Resources

What are the main features of the device?

A combination therapy device, Zilver PTX both restores patency (blood
flow) and provides targeted delivery of paclitaxel, a cell
growth-limiting drug proven to reduce arterial restenosis
(post-procedural blockages). This drug coats the stent without the use
of a polymer, eliminating risks that may arise directly from a polymer.
Zilver PTX is made of nitinol, a "shape memory" metal alloy, and is
engineered to withstand the dynamic forces of the superficial femoral
artery (SFA). Zilver PTX is the first peripheral vascular device that
combines the mechanical support of stenting with the drug paclitaxel to
reduce the risk of restenosis.

What data supports the efficacy of Zilver PTX?3

Two-year data from the Zilver PTX Randomized Controlled Trial of
Paclitaxel-Eluting Stents for Femoropopliteal Disease indicate that the
stent demonstrated 74.8 percent primary patency at 24 months in the PTX
group, compared to just 57.8 percent for patients with optimal
percutaneous transluminal angioplasty and bare metal stents in the 479
patient study.

What is Zilver PTX indicated for and what are the risks and
contraindications for this device?

INDICATIONS: indicated for improving luminal diameter for the
treatment of de novo or restenotic symptomatic lesions in native
vascular disease of the above-the-knee femoropopliteal arteries having
reference vessel diameter from 4mm to 7mm and total lesion lengths up to
140 mm per limb and 280 mm per patient. CONTRAINDICATIONS: Women
who are pregnant, breastfeeding, or plan to become pregnant in the next
5 years should not receive a Zilver PTX Drug-Eluting Peripheral Stent.
Patients who cannot receive recommended anti-platelet and/or
anti-coagulant therapy. Patients judged to have a lesion that prevents
proper placement of the stent or stent delivery system. WARNINGS: Persons
with allergic reactions to nitinol may suffer an allergic reaction to
this implant • Persons allergic to paclitaxel may suffer an allergic
reaction to this implant • The safety and effectiveness of implanting
more than four Zilver PTX Drug Eluting Peripheral Stents in a patient
has not been clinically evaluated. PRECAUTIONS: To avoid
involvement of the common femoral artery, the proximal end of the stent
should be placed at least 1 cm below the origin of the superficial
femoral artery. To avoid involvement of the below-the-knee popliteal
artery, the distal end of the stent should be placed above the plane of
the femoral epicondyles • This product is intended for use by physicians
trained and experienced in diagnostic and interventional vascular
techniques. Standard techniques for interventional vascular procedures
should be employed • Manipulation of the Zilver PTX Drug-Eluting
Peripheral Stent requires fluoroscopic control • Do not try to remove
the stent from the introducer system before use • Ensure that the red
safety lock is not inadvertently removed until final stent release •
Deploy the stent over an extra stiff or ultra stiff wire guide • Do not
push the hub toward the handle during deployment • Do not expose the
delivery system to organic solvents (e.g., alcohol) • Do not use power
injection systems with the delivery system • Do not rotate any part of
the system during deployment • The device is intended for single use
only. Do not resterilize and/or reuse this device • Repositioning of the
device after deployment is not possible since the introducer catheter
cannot be re-advanced over the stent once deployment begins. POTENTIALADVERSE EVENTS: Potential adverse events that may occur include,
but are not limited toAllergic reaction to anticoagulant and/or
antithrombotic therapy or contrast medium• Allergic reaction to
nitinol• Arterial aneurysm• Arterial rupture•
Arterial thrombosis• Arteriovenous fistula•
Atheroembolization (Blue Toe Syndrome)• Death• Embolism• Hematoma/hemorrhage• Hypersensitivity reactions•
Infection• Infection/abscess formation at access site•
Ischemia requiring intervention (bypass or amputation of toe, foot or
leg • Pseudoaneurysm formation• Renal failure•
Restenosis of the stented artery• Stent embolization•
Stent malapposition• Stent migration• Stent strut
fracture• Vessel perforation or rupture• Worsened
claudication/rest pain. Paclitaxel: Although systemic effects are
not anticipated, refer to the Physicians’ Desk Reference for more
information on the potential adverse events observed with paclitaxel.Potential
adverse events, not described in the above source, may be unique to the
paclitaxel drug coating, including• Allergic/immunologic
reaction to the drug coating• Alopecia• Anemia•
Blood product transfusion• Gastrointestinal symptoms•
Hematologic dyscrasia (including leukopenia, neutropenia,
thrombocytopenia)• Hepatic enzyme changes• Histologic
changes in vessel wall, including inflammation, cellular damage, or
necrosis• Myalgia/Arthralgia• Myelosuppression•
Peripheral neuropathy

About Cook Medical

A global pioneer in medical breakthroughs, Cook Medical is committed to
creating effective solutions that benefit millions of patients
worldwide. Today, we combine medical devices, drugs, biologic grafts and
cell therapies across more than 16,000 products serving 41 medical
specialties. Founded in 1963 by a visionary who put patient needs and
ethical business practices first,Cook is a family-owned company
that has created more than 10,000 jobs worldwide. For more information,
visit www.cookmedical.com.
Follow Cook Medical on Twitter
and LinkedIn.

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